Drug Safety Information: FDA
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The U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is responsible for regulating prescription and over-the-counter medications in the U.S.
When a manufacturing company wants to sell a drug, there are several steps it must take before it can receive FDA approval. The company must conduct certain test in labs, on animals, and on humans to make sure the medication is safe for use.
Following appropriate testing, the manufacturing company is required to submit an application to the FDA for approval. The agency will examine the results from the tests, the manufacture information and the label the company would be using on the drug’s packaging.
If the agency decides the benefits of the drug outweigh any potential risks, it will approve the drug for sale.
When Side Effects are Discovered
Sometimes, medications will have risks that are unknown at the time of FDA approval. When these risks are discovered, the FDA will examine the evidence to determine, once again, if the benefits of the drug outweigh the risks.
If the FDA decides that the benefits do in fact outweigh the risks, it will keep the drug on the market, but may require that the manufacturing company add a warning about the potential risks to the drug’s label.
The highest level of warning the FDA gives is called a black box warning. Warnings are issued by the FDA to alert healthcare providers and patients of the potential dangers of the drug. If the FDA determines that a drug’s benefits no longer outweigh the risks, it will request that the manufacturer recall the drug from the market.
Are You Taking a Recalled Drug?
If the medication you are taking is recalled from the market, or if the FDA issues a safety alert to warn patients of potential risks, you should talk to your doctor right away. Your doctor will determine what is right for you, based on factors, including what the medication is for and what the potential dangers are.
Your doctor may want to examine you for potential health complications or may decide to switch you to a safer alternative, even if the drug wasn’t officially recalled. If you hear about a warning, you should speak with your doctor before stopping use on your own. Stopping a medication without instruction from your doctor may put you at risk for other injuries.
Have You Been Injured by a Dangerous Drug?
If you believe that you’ve been harmed by a drug, you may be eligible for financial compensation. To learn more about your legal rights and options, please contact our drug attorneys today.
